Labverity
Facility profile

Cook Incorporated

FDA-registered facility · Bloomington, IN

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

Repack
Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Jun 4, 2025 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2014

More than five years old · review later records.

Understand this record

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Shows

Registration status and a latest matched voluntary action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Method and source details
View full inspection and compliance history20 inspection records

FDA inspection history

20 records, Oct 2010 – Jun 2025 · 5 NAI · 12 VAI · 3 OAI

DateClassProject areaCitationsFY
Jun 4, 2025VAIPostmarket Assurance: DevicesYes2025
Jun 4, 2025VAICompliance: DevicesYes2025
May 8, 2024VAICompliance: DevicesYes2024
Sep 14, 2021VAIPostmarket Assurance: DevicesYes2021
Sep 14, 2021VAICompliance: DevicesYes2021
Feb 7, 2020VAICompliance: DevicesYes2020
Jun 14, 2018NAIPostmarket Assurance: DevicesYes2018
Jun 14, 2018VAICompliance: DevicesYes2018
Jan 26, 2017VAIPostmarket Assurance: DevicesYes2017
Jan 26, 2017VAICompliance: DevicesYes2017
Mar 13, 2015VAICompliance: DevicesYes2015
Mar 13, 2015NAIPostmarket Assurance: DevicesYes2015
Jul 16, 2014OAICompliance: Devices2014
Jul 16, 2014OAIBioresearch Monitoring2014
Jul 16, 2014OAIPostmarket Assurance: Devices2014
Aug 2, 2013NAICompliance: Devices2013
Aug 2, 2013NAIBioresearch Monitoring2013
Jul 26, 2012VAIBioresearch MonitoringYes2012
Jul 26, 2012VAICompliance: DevicesYes2012
Oct 5, 2010NAICompliance: Devices2011

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

Sep 16, 2014Warning Letter · CDRH
Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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